$VANI
Vivani Medical, Inc.

2024 Q4 Form 10-Q Financial Statement

#000175392624001874 Filed on November 13, 2024

View on sec.gov

Income Statement

Concept 2024 Q4 2024 Q3
Revenue $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $2.106M
YoY Change -22.0%
% of Gross Profit
Research & Development $4.203M
YoY Change -5.36%
% of Gross Profit
Depreciation & Amortization $112.0K
YoY Change 60.0%
% of Gross Profit
Operating Expenses $6.309M
YoY Change -11.69%
Operating Profit -$6.309M
YoY Change -11.69%
Interest Expense
YoY Change
% of Operating Profit
Other Income/Expense, Net $268.0K
YoY Change -25.56%
Pretax Income -$6.041M
YoY Change -10.9%
Income Tax
% Of Pretax Income
Net Earnings -$6.041M
YoY Change -10.93%
Net Earnings / Revenue
Basic Earnings Per Share -$0.11
Diluted Earnings Per Share -$0.11
COMMON SHARES
Basic Shares Outstanding 59.23M shares 55.26M shares
Diluted Shares Outstanding 55.25M shares

Balance Sheet

Concept 2024 Q4 2024 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $19.65M
YoY Change -20.85%
Cash & Equivalents $19.65M
Short-Term Investments
Other Short-Term Assets $1.753M
YoY Change -70.09%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $21.40M
YoY Change -30.26%
LONG-TERM ASSETS
Property, Plant & Equipment $1.644M
YoY Change 44.97%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments $132.0K
YoY Change 46.67%
Other Assets $1.338M
YoY Change -2.05%
Total Long-Term Assets $21.50M
YoY Change -5.04%
TOTAL ASSETS
Total Short-Term Assets $21.40M
Total Long-Term Assets $21.50M
Total Assets $42.90M
YoY Change -19.55%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $815.0K
YoY Change -56.9%
Accrued Expenses $2.024M
YoY Change 11.52%
Deferred Revenue
YoY Change
Short-Term Debt $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $6.270M
YoY Change -15.65%
LONG-TERM LIABILITIES
Long-Term Debt $0.00
YoY Change
Other Long-Term Liabilities $18.29M
YoY Change -7.04%
Total Long-Term Liabilities $18.29M
YoY Change -7.04%
TOTAL LIABILITIES
Total Short-Term Liabilities $6.270M
Total Long-Term Liabilities $18.29M
Total Liabilities $24.56M
YoY Change -9.4%
SHAREHOLDERS EQUITY
Retained Earnings -$115.9M
YoY Change 25.39%
Common Stock $6.000K
YoY Change 20.0%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $18.33M
YoY Change
Total Liabilities & Shareholders Equity $42.90M
YoY Change -19.55%

Cashflow Statement

Concept 2024 Q4 2024 Q3
OPERATING ACTIVITIES
Net Income -$6.041M
YoY Change -10.93%
Depreciation, Depletion And Amortization $112.0K
YoY Change 60.0%
Cash From Operating Activities -$5.661M
YoY Change -26.48%
INVESTING ACTIVITIES
Capital Expenditures $41.00K
YoY Change -31.67%
Acquisitions
YoY Change
Other Investing Activities
YoY Change
Cash From Investing Activities -$41.00K
YoY Change -31.67%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 427.0K
YoY Change 327.0%
NET CHANGE
Cash From Operating Activities -5.661M
Cash From Investing Activities -41.00K
Cash From Financing Activities 427.0K
Net Change In Cash -5.275M
YoY Change -31.14%
FREE CASH FLOW
Cash From Operating Activities -$5.661M
Capital Expenditures $41.00K
Free Cash Flow -$5.702M
YoY Change -26.52%

Facts In Submission

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vani Proceeds From Issuance Of Common Stock And Warrants In Connection With At Market Offering Net Of Issuance Costs
ProceedsFromIssuanceOfCommonStockAndWarrantsInConnectionWithAtMarketOfferingNetOfIssuanceCosts
160000 usd
vani Proceeds From Issuance Of Common Stock And Warrants In Connection With At Market Offering Net Of Issuance Costs
ProceedsFromIssuanceOfCommonStockAndWarrantsInConnectionWithAtMarketOfferingNetOfIssuanceCosts
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vani Proceeds From Insurance Premium Loan
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379000 usd
vani Proceeds From Insurance Premium Loan
ProceedsFromInsurancePremiumLoan
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us-gaap Net Cash Provided By Used In Financing Activities
NetCashProvidedByUsedInFinancingActivities
14226000 usd
us-gaap Net Cash Provided By Used In Financing Activities
NetCashProvidedByUsedInFinancingActivities
110000 usd
us-gaap Effect Of Exchange Rate On Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
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us-gaap Effect Of Exchange Rate On Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
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-3000 usd
us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Including Exchange Rate Effect
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-1008000 usd
us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Including Exchange Rate Effect
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsPeriodIncreaseDecreaseIncludingExchangeRateEffect
-20255000 usd
CY2023Q4 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
21992000 usd
CY2022Q4 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
46442000 usd
CY2024Q3 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
20984000 usd
CY2023Q3 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
26187000 usd
us-gaap Income Taxes Paid Net
IncomeTaxesPaidNet
2000 usd
us-gaap Income Taxes Paid Net
IncomeTaxesPaidNet
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vani Establishment Of Operating Rightofuse Assets Through Operating Lease Obligations
EstablishmentOfOperatingRightofuseAssetsThroughOperatingLeaseObligations
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vani Establishment Of Operating Rightofuse Assets Through Operating Lease Obligations
EstablishmentOfOperatingRightofuseAssetsThroughOperatingLeaseObligations
20755000 usd
us-gaap Nature Of Operations
NatureOfOperations
<p id="xdx_801_eus-gaap--NatureOfOperations_zXGGpdvGBTN2" style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;"><b>Note 1. <span>Organization and Business Operations</span></b></span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;"> </span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;">Vivani Medical, Inc. (“Vivani,” the “Company,” “we,” “us,” “our” or similar terms) is a preclinical stage biopharmaceutical company which develops miniaturized, subdermal implants utilizing its proprietary NanoPortal™ technology, <span style="line-height: inherit;">which is designed to</span> enable long-term, near constant-rate delivery of a broad range of medicines to treat chronic diseases. Vivani uses this platform technology to develop and potentially commercialize drug implant candidates, alone or in collaboration with pharmaceutical company partners to address a leading cause of poor clinical outcomes in the treatment of chronic disease, medication non-adherence. According to the U.S. Centers for Disease Control and Prevention, adherence is defined as the extent to which an individual’s behavior, including taking medications, corresponds to recommendations from a health care provider. </span><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;">An alarmingly high proportion of patients, approximately 50%, do not take their medicine as prescribed in the real world, a statistic that applies to both daily oral as well as weekly injectable medicines. For example, a recent study has shown that 64% of patients taking Wegovy® (semaglutide injectable) discontinue therapy within the first year of treatment, a number that increases to 76% by the second year. Unfortunately, GLP-<span>1</span> discontinuation may result in a quick reversal of the health benefits in the majority of patients. </span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><br/></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;">At Vivani, we are developing a portfolio of miniature, <span style="line-height: inherit;"><span style="line-height: inherit;">subdermal</span></span> drug implant candidates that, unlike most oral and injectable medicines, are designed with the goal of guaranteeing medication adherence by delivering therapeutic drug levels for up to <span style="border-right: none; border-left: none;">six months</span> or longer. In addition, our aim is to minimize fluctuations in patients’ drug levels through the use of our NanoPortal™ technology, which may improve the tolerability profiles for medicines, including GLP-<span>1</span> receptor agonists, that produce side effects associated with fluctuating drug levels in the blood.</span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0px; text-indent: 0px;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;"> </span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;">Vivani resulted from the business combination of Second Sight Medical Products, Inc. (“Second Sight”) and Nano Precision Medical, Inc. (“NPM”). On August 30, 2022, Second Sight and NPM completed their merger pursuant to which NPM became a wholly owned subsidiary of Second Sight and the combined company of NPM and Second Sight was renamed Vivani Medical, Inc. Vivani’s main priority is the further development of its lead program NPM-<span>115</span>, a miniature, <span>6</span>-month, GLP-<span>1</span> implant candidate for chronic weight management in obese or overweight patients with <span>one</span> or more risk factors and further development of the balance of company’s miniature, long-acting drug implant portfolio. In parallel, Vivani’s management team <span style="line-height: inherit;">remains</span> committed to identifying and exploring strategic options that will enable further development of its pioneering neurostimulation systems from legacy company Second Sight aimed at helping patients recover critical body functions.</span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><br/></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;">In December 2022, we contributed our neurostimulation assets and certain liabilities to Cortigent, Inc. (“Cortigent”), a wholly owned subsidiary of Vivani. Cortigent has 5,000,000 shares of common stock outstanding, all owned by Vivani. Cortigent is advancing the Company’s pioneering neurostimulation technology. In March 2023, Vivani announced the filing of a Registration Statement on Form S-<span>1</span> with the U.S. Securities and Exchange Commission (“SEC”) for the proposed initial public offering of Cortigent. The Registration Statement on Form S-<span>1</span> was recently amended and filed with the SEC on September 4, 2024 to refresh the financial information and provide minor updates to the business.</span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0px; text-indent: 0px;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;"> </span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;">On July 6, 2023, Vivani changed its state of incorporation from the State of California to the State of Delaware by means of a plan of conversion, effective July 5, 2023. The reincorporation, including the principal terms of the plan of conversion, was submitted to a vote of, and approved by, Vivani’s stockholders at its <span>2023</span> Annual Meeting of Stockholders held on June 15, 2023. As part of this change of incorporation the Company established a par value of $0.0001 per share and all periods have been retroactively adjusted to reflect this change.</span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;"> </span></p> <p style="margin: 0in 0in 0pt; line-height: 1.2; font-size: 10pt; font-family: Calibri, sans-serif; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;">A<span style="line-height: inherit;">n Investigational New Drug Application (“IND”) for NPM-<span>119</span> (GLP-<span>1</span> implant) was filed with the U.S. Food and Drug Administration (“FDA”) on July 14, 2023, to support the initiation of a first-in-human study of an exenatide implant in patients with type <span>2</span> diabetes. On August 18, 2023, FDA provided written notification that the study was on full clinical hold, primarily due to insufficient Chemistry, Manufacturing, and Controls (“CMC”) information to assess the risk to human subjects. After providing additional information to sufficiently address the FDA's requests, the FDA lifted the clinical hold on NPM-<span>119</span> on June 13, 2024 allowing for the proposed study to proceed. The primary objective of this first-in-human clinical study was to evaluate the safety, tolerability and pharmacokinetics of NPM-<span>119</span> in type <span>2</span> diabetes patients. The initial study design also incorporated Bydureon BCise® (exenatide injection) for comparison purposes.</span></span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><br/></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;">On August 25, 2023, the Company and Cortigent entered into an Amendment <span>1</span> (the “Amendment”) to the Transition Funding, Support and Services Agreement dated March 19, 2023 (the “TFSSA”). Pursuant to the TFSSA, Vivani has agreed to advance funds and provide or cause to be provided to Cortigent the services and funding intended to cover salaries and related costs, rent and other overhead in order to permit Cortigent to operate in substantially the same manner in which business operations of Cortigent were previously operated by Second Sight, prior to the formation of Cortigent, which obligations will continue, in the case of the funding obligations, until the earlier of December 31, 2024 or the closing of an initial public offering of Cortigent (the “Funding Support Term”). Under the Amendment, Cortigent has agreed to repay $<span>1,500,000</span> to Vivani at the conclusion of the Funding Support Term. In addition, at the conclusion of the Funding Support Term, Cortigent will enter into a <span style="-sec-ix-hidden:Tag706"><span><span style="border-left: none; border-right: none;">five</span></span>-year</span> promissory note at <span>5</span>% interest for $<span>2,000,000</span> in favor of Vivani. Consequently, Vivani will forgive any remaining amounts due by Cortigent to the Company under the TFSSA. In October 2023, Vivani implemented a reduction-in-force to conserve cash that decreased Cortigent’s employees from 14 to 7 while continuing the ongoing Orion<span style="font-size: 8pt;"><sup>®</sup></span> clinical study and basic operations.</span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;"> </span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;">In the fourth quarter of <span>2023</span>, Vivani Medical Australia Pty Ltd., a wholly owned subsidiary in Australia was established to support studies of our product candidates.</span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;"> </span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;">In February 2024, Vivani announced positive preclinical weight loss data with its exenatide implant that was comparable to semaglutide, the active ingredient in Ozempic<span style="font-size: 8pt;"><sup>®</sup></span>/Wegovy<span style="font-size: 8pt;"><sup>®</sup></span>, and a strategic shift to prioritize the Company's obesity portfolio. In a study of high-fat diet-induced obese mice, the exenatide implant generated weight loss of approximately 20% compared to a sham implant control after a 28-day treatment duration, comparable to the extent of weight loss observed in mice treated with semaglutide injections (Ozempic<span style="font-size: 8pt;"><sup>®</sup></span>) in the same study.</span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><br/></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;">In February, the Company also disclosed that semaglutide is the active pharmaceutical ingredient in NPM-<span>139</span>, another miniature, long term subdermal GLP-<span>1</span> implant in development for chronic weight management further demonstrating our prioritization on obesity. NPM-<span>139</span> also has the added potential benefit of once-yearly administration.</span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><br/></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;">On March 1, 2024, <span><span style="border-left: none; border-right: none;">the Company entered into a securities purchase agreement (“Securities Purchase Agreement”) with an institutional investor to purchase 3,947,368 shares of common stock, par value $0.0001 per share (the “Common Stock”) and warrants to purchase up to an aggregate of 3,947,368 shares of common stock at a purchase price of $3.80 per share and accompanying warrant in a registered direct offering (the “Offering”). The warrants have an exercise price of $3.80 per share, are exercisable immediately upon issuance, and will expire three years following the date of issuance.</span></span></span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;"> </span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;">On April 22, 2024, the Company entered into an Open Market Sale Agreement<span style="font-size: 8pt;"><sup>SM</sup></span> (the “Sales Agreement”) with Jefferies LLC (“Jefferies”), under which the Company may offer and sell, from time to time at its sole discretion, shares of the common stock, having an aggregate offering price of up to $75.0 million through Jefferies as its sales agent. Also on April 22, 2024, the Company filed a Registration Statement on Form S-<span>3</span>, which was declared effective on May 3, 2024, including a sales agreement prospectus relating to the offering of up to $75.0 million shares of its common stock in accordance with the Sales Agreement.</span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><br/></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;">On May 28, 2024, Vivani announced the publication of positive weight loss data supporting the potential veterinary use of OKV-<span>119</span>, the company's miniature, long-acting GLP-<span>1</span> implant under development with partner Okava Pharmaceuticals, Inc. ("Okava") for the treatment of pre-diabetes, diabetes and obesity in companion felines. The device is intended to be conveniently inserted under the skin during routine veterinary visits and is being designed to deliver <span style="border-left: none; border-right: none;">six months</span> of GLP-<span>1</span> therapy with a single administration.  </span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><br/></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;">As stated previously, on June 13, 2024, Vivani announced that the FDA cleared the IND and lifted the clinical hold for NPM-<span>119</span>, the Company's miniature, <span>six</span>-month GLP-<span>1</span> implant under development for the treatment of patients with type <span>2</span> diabetes.</span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><br/></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;">On July 11, 2024, the Company provided an update of the clinical development plans for NPM-<span>115</span>, the clinical program associated with the miniature, long-acting GLP-<span>1</span> (high-dose exenatide) implant for chronic weight management in obese and overweight individuals. The Company has redesigned the First-in-Human study, LIBERATE-<span>1</span>, initially intended to explore the safety, tolerability and pharmacokinetics of its exenatide implant in patients with type <span>2</span> diabetes, to evaluate the implant in obese and overweight patients. The study will enroll patients who will be titrated on weekly semaglutide injections for eight weeks before being randomized to receive a single exenatide implant, weekly exenatide injections (Bydureon BCise<span style="font-size: 8pt;"><sup>®</sup></span>) or weekly semaglutide injections (Wegovy<span style="font-size: 8pt;"><sup>®</sup></span>) for a nine-week treatment duration. The LIBERATE-<span style="display: inline;">1</span> study will be conducted in Australia and is anticipated to be initiated in the fourth quarter of <span style="display: inline;">2024</span>, subject to regulatory clearance, with data from the study expected in <span style="display: inline;">2025</span>.</span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;"><br/></span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt;"><span>On September 4, 2024, </span>Vivani<span> announced positive preclinical liver fat results with its miniature, ultra long-acting GLP-1 </span></span><span style="font-family: 'times new roman', times; font-size: 10pt;">implant currently under development chronic weight management in obese and overweight individuals and type 2 diabetes. The Company's GLP-1 (exenatide) implant produced sham-implant adjusted liver fat reduction of 82% in an obese mouse model from a single administration with expected twice-yearly dosing. These liver fat data are consistent with published results from similar investigations with semaglutide, the active pharmaceutical ingredient in Ozempic<span>®</span> and Wegovy<span>®</span>.</span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit; margin: 0pt 0px; text-indent: 0.25in;"><br/></span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit; margin: 0pt 0px; text-indent: 0.25in;">On September 26, 2024, the Company reported receiving regulatory approval to initiate its first in human clinical trial with a miniature, ultra long-acting GLP-1 (exenatide) implant in obese and overweight individuals in Australia. This clinical trial, known as LIBERATE-1™, is part of the NPM-115 program and will investigate the safety, tolerability and full pharmacokinetic profile of an exenatide implant. The trial also represents the first clinical application of the Company’s proprietary NanoPortal™ drug implant technology. LIBERATE-1 is designed to enroll participants who will be titrated on weekly semaglutide injections for <span style="border-right: none; border-left: none;">8 weeks</span> (0.25 mg/week for 4 weeks followed by 0.5 mg/week for 4 weeks) before being randomized to receive a single administration of Vivani’s exenatide implant (n=8), weekly exenatide injections (n=8), or weekly 1 mg semaglutide injections (n=8) for a <span style="border-left: none; border-right: none;">9-week</span> treatment duration. Changes in weight will be measured. The trial is expected to be initiated later this year with data projected to be available in 2025.</span></p> <p style="margin: 0pt; font-family: 'times new roman'; font-size: 10pt;"><span style="font-family: 'times new roman'; font-size: 10pt;"> </span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;"><b>Liquidity and Capital Resources</b></span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px;"><br/></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;">From inception, our operations have been funded primarily through the sales of our common stock and warrants.</span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt; text-indent: 0px;"> </span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;">Our financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. We are subject to the risks and uncertainties associated with a business with no revenue that is developing novel medical devices, including limitations on our operating capital resources. We have incurred recurring operating losses and negative operating cash flows since inception, and we expect to continue to incur operating losses and negative operating cash flows for the foreseeable future.</span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><br/></p> <p style="font: 10pt / 1.2 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.3in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;">On March 1, 2024, <span><span style="border-left: none; border-right: none;">the Company entered into the Securities Purchase Agreement relating to the issuance of 3,947,368 shares of the common stock and warrants to purchase up to an aggregate of 3,947,368 shares of common stock (the “Warrants”), to such investor at a purchase price of $3.80 per share and accompanying warrants in the Offering. The Warrants have an exercise price of $3.80 per share, are exercisable immediately upon issuance and will expire <span style="border-left: none; border-right: none;">three years</span> following the date of issuance.</span></span> Simultaneously, the Company also entered into a placement agency agreement with Maxim Group LLC (“Maxim” and such agreement, the “Placement Agency Agreement,” and together with the Securities Purchase Agreement, the “Agreements”), who acted as the sole placement agent for the Offering. The gross proceeds of $<span>15.0</span> million from the Offering, before paying the placement agent fees and other offering costs, were received on March 5, 2024. In connection with the Securities Purchase Agreement, the Company paid issuance costs of <span style="line-height: inherit;">$1.3 million, resulting in net proceeds of $13.7 million</span>. For additional information, refer to Note <span>7</span>. Equity Securities of the Notes to Condensed Consolidated Financial Statements.</span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0px; text-indent: 0px;"><br/></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.3in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;">On April 22, 2024, the Company entered into the Sales Agreement with Jefferies, under which the Company may offer and sell, from time to time at its sole discretion, shares of the common stock, having an aggregate offering price of up to $75.0 million through Jefferies as its sales agent. Also on April 22, 2024, the Company filed a Registration Statement on Form S-<span>3</span>, which was declared effective on May 3, 2024, including a sales agreement prospectus relating to the offering of up to $75.0 million shares of its common stock in accordance with the Sales Agreement. For additional information, refer to Note <span>7</span>. Equity Securities of the Notes to Condensed Consolidated Financial Statements.</span></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.3in;"><br/></p> <p style="font: 10pt 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.3in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;">We estimate that currently available cash will provide sufficient funds to enable the Company to meet its planned obligations <span style="font-size: 10.0pt; font-family: 'Times New Roman',serif; mso-fareast-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">for at least the next twelve months</span>. Our ability to continue as a going concern is dependent on our ability to develop profitable operations through implementation of our business initiatives and/or raise additional capital, however, there can be no assurances that we will be able to do so.</span></p>
vani Percentage Of Patients Do Not Take Their Medicine As Prescribed In Real World
PercentageOfPatientsDoNotTakeTheirMedicineAsPrescribedInRealWorld
0.50 pure
vani Percentage Of Patients Taking Wegovy Semaglutide Injectable Discontinue Therapy Within First Year Of Treatment
PercentageOfPatientsTakingWegovySemaglutideInjectableDiscontinueTherapyWithinFirstYearOfTreatment
0.64 pure
vani Percentage Of Patients Taking Wegovy Semaglutide Injectable Discontinue Therapy Within Second Year Of Treatment
PercentageOfPatientsTakingWegovySemaglutideInjectableDiscontinueTherapyWithinSecondYearOfTreatment
0.76 pure
CY2023Q3 us-gaap Common Stock Par Or Stated Value Per Share
CommonStockParOrStatedValuePerShare
0.0001
CY2024Q1 vani Percentage Of Weight Loss After Exenatide Implant Therapy For Patients Whom Has High Fat Diet Induced Obese Mice
PercentageOfWeightLossAfterExenatideImplantTherapyForPatientsWhomHasHighFatDietInducedObeseMice
0.20 pure
CY2024Q1 vani Period Of Sham Implant Control Therapy
PeriodOfShamImplantControlTherapy
P28D
CY2024Q2 vani Period Of Specific Therapy With Single Administration
PeriodOfSpecificTherapyWithSingleAdministration
P6M
CY2024Q3 vani Number Of Weeks Before Being Randomized To Receive Therapy
NumberOfWeeksBeforeBeingRandomizedToReceiveTherapy
8
CY2024Q3 vani Number Of Weeks For Weekly Semaglutide Injections Therapy
NumberOfWeeksForWeeklySemaglutideInjectionsTherapy
9
CY2024Q3 vani Percentage Of Liver Fat Reduction After Exenatide Implant Therapy For Patients Whom Has High Fat Diet Induced Obese Mice
PercentageOfLiverFatReductionAfterExenatideImplantTherapyForPatientsWhomHasHighFatDietInducedObeseMice
0.82 pure
CY2024Q3 vani Number Of Weeks Before Being Randomized To Receive Therapy
NumberOfWeeksBeforeBeingRandomizedToReceiveTherapy
8
CY2024Q3 vani Number Of Weeks For Weekly Semaglutide Injections Therapy
NumberOfWeeksForWeeklySemaglutideInjectionsTherapy
9
us-gaap Revenue From Contract With Customer Including Assessed Tax
RevenueFromContractWithCustomerIncludingAssessedTax
0 usd
CY2024Q3 us-gaap Common Stock Shares Outstanding
CommonStockSharesOutstanding
55266435 shares
CY2024Q3 us-gaap Common Stock Shares Issued
CommonStockSharesIssued
55266435 shares
CY2024Q3 us-gaap Preferred Stock Shares Authorized
PreferredStockSharesAuthorized
10000000 shares
CY2024Q3 us-gaap Preferred Stock Shares Issued
PreferredStockSharesIssued
0 shares
us-gaap Use Of Estimates
UseOfEstimates
<p id="xdx_842_eus-gaap--UseOfEstimates_zbNGHDBldQx4" style="font: 10pt / 1.2 'Times New Roman', Times, serif; margin: 0pt 0px;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;"><i><span>Use of estimates</span></i></span></p> <p style="font: 10pt / 1.2 'Times New Roman', Times, serif; margin: 0pt 0px;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;"> </span></p> <p style="font: 10pt / 1.2 'Times New Roman', Times, serif; margin: 0pt 0px; text-indent: 0.25in;"><span style="font-family: 'times new roman', times; font-size: 10pt; line-height: inherit;">The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of expenses during the <span style="background-color: white; line-height: inherit;">reporting </span>periods. On an ongoing basis, management evaluates its estimates, including, but not limited to, those related to useful lives of long-lived assets, stock-based compensation and evaluation of going concern. Management bases its estimates on historical experience and on various assumptions that management believes to be reasonable under the circumstances. Actual results could differ materially from those estimates.</span></p>
us-gaap Number Of Operating Segments
NumberOfOperatingSegments
2 segment
CY2024Q3 us-gaap Cash And Cash Equivalents Fair Value Disclosure
CashAndCashEquivalentsFairValueDisclosure
18224000 usd
CY2023Q4 us-gaap Cash And Cash Equivalents Fair Value Disclosure
CashAndCashEquivalentsFairValueDisclosure
18629000 usd
CY2024Q3 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
4186000 usd
CY2023Q4 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
4171000 usd
CY2024Q3 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
2542000 usd
CY2023Q4 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
2442000 usd
CY2024Q3 us-gaap Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
1644000 usd
CY2023Q4 us-gaap Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
1729000 usd
CY2024Q3 us-gaap Common Stock Shares Authorized
CommonStockSharesAuthorized
300000000 shares
CY2024Q3 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
472 usd
CY2023Q3 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
511 usd
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
1208 usd
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
1404 usd
CY2024Q3 us-gaap Net Income Loss
NetIncomeLoss
-6041000 usd
CY2023Q3 us-gaap Net Income Loss
NetIncomeLoss
-6782000 usd
us-gaap Net Income Loss
NetIncomeLoss
-17436000 usd
us-gaap Net Income Loss
NetIncomeLoss
-19626000 usd
CY2024Q3 us-gaap Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
55247000 shares
CY2024Q3 us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
55247000 shares
CY2023Q3 us-gaap Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
50837000 shares
CY2023Q3 us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
50837000 shares
us-gaap Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
54161000 shares
us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
54161000 shares
us-gaap Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
50757000 shares
us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
50757000 shares
CY2024Q3 us-gaap Earnings Per Share Diluted
EarningsPerShareDiluted
-0.11
CY2024Q3 us-gaap Earnings Per Share Basic
EarningsPerShareBasic
-0.11
CY2023Q3 us-gaap Earnings Per Share Diluted
EarningsPerShareDiluted
-0.13
CY2023Q3 us-gaap Earnings Per Share Basic
EarningsPerShareBasic
-0.13
us-gaap Earnings Per Share Diluted
EarningsPerShareDiluted
-0.32
us-gaap Earnings Per Share Basic
EarningsPerShareBasic
-0.32
us-gaap Earnings Per Share Diluted
EarningsPerShareDiluted
-0.39
us-gaap Earnings Per Share Basic
EarningsPerShareBasic
-0.39
us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
17416 shares
us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
16757 shares
vani Maximum Period For Lease Term Which Are Not Recorded On Balance Sheet
MaximumPeriodForLeaseTermWhichAreNotRecordedOnBalanceSheet
P12M
CY2023Q1 us-gaap Lessor Operating Lease Description
LessorOperatingLeaseDescription
lease 14,823 square feet of office space at 27200 Tourney Road, Valencia, California 91355.
CY2023Q1 us-gaap Lessee Finance Sublease Option To Extend
LesseeFinanceSubleaseOptionToExtend
The sublease has a term of two years and two months. We also entered into a lease for storage space on January 25, 2023, in the same building at a cost of $6,775 per month for a term of two years and one month.
CY2024Q3 us-gaap Operating Lease Right Of Use Asset
OperatingLeaseRightOfUseAsset
18383000 usd
CY2023Q4 us-gaap Operating Lease Right Of Use Asset
OperatingLeaseRightOfUseAsset
19616000 usd
CY2024Q3 us-gaap Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
1385000 usd
CY2023Q4 us-gaap Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
1383000 usd
CY2024Q3 us-gaap Liabilities Other Than Longterm Debt Noncurrent
LiabilitiesOtherThanLongtermDebtNoncurrent
18294000 usd
CY2023Q4 us-gaap Liabilities Other Than Longterm Debt Noncurrent
LiabilitiesOtherThanLongtermDebtNoncurrent
19313000 usd
CY2024Q3 us-gaap Operating Lease Cost
OperatingLeaseCost
800000 usd
CY2023Q3 us-gaap Operating Lease Cost
OperatingLeaseCost
1100000 usd
us-gaap Operating Lease Cost
OperatingLeaseCost
1900000 usd
CY2024Q3 us-gaap Utilities Operating Expense Maintenance
UtilitiesOperatingExpenseMaintenance
100000 usd
CY2023Q3 us-gaap Utilities Operating Expense Maintenance
UtilitiesOperatingExpenseMaintenance
400000 usd
us-gaap Utilities Operating Expense Maintenance
UtilitiesOperatingExpenseMaintenance
300000 usd
us-gaap Utilities Operating Expense Maintenance
UtilitiesOperatingExpenseMaintenance
600000 usd
CY2024Q3 us-gaap Lessee Operating Lease Liability Payments Remainder Of Fiscal Year
LesseeOperatingLeaseLiabilityPaymentsRemainderOfFiscalYear
775000 usd
CY2024Q3 us-gaap Lessee Operating Lease Liability Payments Due Next Twelve Months
LesseeOperatingLeaseLiabilityPaymentsDueNextTwelveMonths
2914000 usd
CY2024Q3 us-gaap Lessee Operating Lease Liability Payments Due Year Two
LesseeOperatingLeaseLiabilityPaymentsDueYearTwo
2889000 usd
CY2024Q3 us-gaap Lessee Operating Lease Liability Payments Due Year Three
LesseeOperatingLeaseLiabilityPaymentsDueYearThree
2976000 usd
CY2024Q3 us-gaap Lessee Operating Lease Liability Payments Due Year Four
LesseeOperatingLeaseLiabilityPaymentsDueYearFour
3065000 usd
CY2024Q3 us-gaap Lessee Operating Lease Liability Payments Due After Year Five
LesseeOperatingLeaseLiabilityPaymentsDueAfterYearFive
15862000 usd
CY2024Q3 us-gaap Lessee Operating Lease Liability Payments Due
LesseeOperatingLeaseLiabilityPaymentsDue
28481000 usd
CY2024Q3 us-gaap Lessee Operating Lease Liability Undiscounted Excess Amount
LesseeOperatingLeaseLiabilityUndiscountedExcessAmount
8802000 usd
CY2024Q3 us-gaap Operating Lease Liability
OperatingLeaseLiability
19679000 usd
CY2024Q3 us-gaap Operating Lease Weighted Average Discount Rate Percent
OperatingLeaseWeightedAverageDiscountRatePercent
0.084 pure
CY2024Q3 us-gaap Operating Lease Weighted Average Remaining Lease Term1
OperatingLeaseWeightedAverageRemainingLeaseTerm1
P8Y10M24D
CY2024Q3 vani Cash Paid For Operating Lease Liabilities
CashPaidForOperatingLeaseLiabilities
776000 usd
CY2023Q3 vani Cash Paid For Operating Lease Liabilities
CashPaidForOperatingLeaseLiabilities
375000 usd
vani Cash Paid For Operating Lease Liabilities
CashPaidForOperatingLeaseLiabilities
2294000 usd
vani Cash Paid For Operating Lease Liabilities
CashPaidForOperatingLeaseLiabilities
1134000 usd
CY2024Q3 vani Clinical And Regulatory Expense
ClinicalAndRegulatoryExpense
3000 usd
CY2023Q3 vani Clinical And Regulatory Expense
ClinicalAndRegulatoryExpense
4000 usd
vani Clinical And Regulatory Expense
ClinicalAndRegulatoryExpense
13000 usd
CY2021Q2 vani Liquidated Damages Paid Value
LiquidatedDamagesPaidValue
1000000 usd
us-gaap Contract Termination Claims Description
ContractTerminationClaimsDescription
Pixium indicated that it considered this termination wrongful, rejected the Company’s offers, but retained the $1,000,000 payment. On May 19, 2021, Pixium filed suit in the Paris Commercial Court, and currently claim damages of approximately €5.1 million or about $5.6 million. We believe we have fulfilled our obligations to Pixium with the liquidated damages payment of $1,000,000.
CY2021Q2 us-gaap Loss Contingency Damages Paid Value
LossContingencyDamagesPaidValue
1000000 usd
CY2021Q2 us-gaap Loss Contingency Damages Sought Value
LossContingencyDamagesSoughtValue
5100000 eur
CY2021Q2 us-gaap Loss Contingency Damages Sought Value
LossContingencyDamagesSoughtValue
5600000 usd
CY2022Q4 us-gaap Loss Contingency Settlement Agreement Court
LossContingencySettlementAgreementCourt
On December 8, 2022, the Company received notice that the Paris Commercial Court has rendered its judgment, including finding that the Company’s termination of the MOU was not valid. In the judgment, the Company was ordered to pay to Pixium the amount of €2,500,000 minus a €947,780 credit for the $1,000,000 already paid for, a net amount payable of approximately €1,552,220. On May 24, 2023, the Company filed an appeal against the judgment from the Paris Commercial Court except in so far as such prior judgment dismissed (i) Pixium’s claim for the Company to pay it a sum of €480,693 relating to the alleged time spent by its teams, (ii) Pixium’s application to order the Company to pay it a sum of €1,500,000 in respect to alleged loss of opportunity and (iii) deducted the sum of $1,000,000 that we already paid Pixium and which Pixium retained converted into euros at the date of the judgment. Thereafter Pixium filed its brief with Paris Court of Appeal and filed a cross-appeal on January 18, 2024. Meanwhile, the Company received notice that the Paris Commercial Court had opened safeguard proceedings against Pixium by judgment dated October 9, 2023, then in its judgment dated November 13, 2023, converted safeguard proceedings into receivership, and in its judgment dated January 31, 2024, converted Pixium’s receivership proceedings to liquidation proceedings, the transfer plan being rejected. As a result, Pixium’s liquidator intervened on behalf of Pixium in the pending proceedings before the Paris Court of Appeal and filed its brief on March 21, 2024. The Company filed its brief in reply with the Paris Court of Appeal on April 17, 2024. Proceedings before the Paris Court of Appeal are pending. In parallel, since the Company has failed to enforce the judgment, Pixium has requested the pre-trial judge to strike out the Company's appeal for failure to enforce the judgment. The hearing took place on June 4, 2024 and on October 23, 2024, the pre-trial judge issued his order, striking out Vivani's appeal for failure to enforce the decision. Within two years, Vivani will have to request that the case be reinstated on the court's docket, providing evidence that the judgment has been fully enforced or, at the very least, that an agreement has been reached. Failing this, the appeal proceedings will lapse.
CY2022 us-gaap Loss Contingency Loss In Period
LossContingencyLossInPeriod
1675000 usd
CY2024Q3 ecd Trd Arr Securities Agg Avail Amt
TrdArrSecuritiesAggAvailAmt
3968253 shares

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